Novel food waiting may reduce to one year

Changes to the European novel food regulation could bring the
waiting time for approval down from around three years to just one,
according to the European Advisory Service.

The European Commission's revision of the rule is aimed at
simplifying the process and fostering industry innovation.
In the EU, a food is judged to be novel if it was not eaten in a
significant quantity in Europe before May 1997.
According to the EU Novel Foods Regulation (EC) 258/97, new food
ingredients must be shown to meet three criteria before they can be
authorised for sale: they must not be unsafe, their labelling must
not be misleading and their nutritional quality must not be
inferior to other similar foods that they could replace.
Novel food qualification covers food groups such as plant algae,
fungi microorganisms and animal derived foods, but also foods that
have altered compositional structure.
EAS regulatory adviser Pieter Lagae said that the revision could
significantly reduce the waiting time for approval.
It is feared that the novel food regulation as it stands stifles
innovation as companies wishing to use a new ingredient in a
supplement or fortified food have a long wait on their hands for
approval.
He said: "It is well known that a three year novel food
procedure is very common. First you have the member state
assessment followed by the commission sending it to the other
member states, then they have 60 days to comment. After which the
commission will consult with the European Food Safety Authority
(EFSA) which will then issue an opinion. It can be a year after
then before a decision is reached." ​
The draft of the revision, which is being prepared by the
Commission, would reduce the amount of assessment an application
has to go through. Instead, EFSA will immediately assess the
application and not the member state.
"It, however, remains to be seen if this shall be the case. It
is mainly due to the fact that EFSA has 180 days for its risk
assessment, there is no member state assessment in advance​,"
he said.
While this would reduce the timing of assessment, it might not make
the novel food rules any clearer. Lagae added: "On the other
hand the revision may not necessarily or immediately result in more
clarity for company that is asking whether or not they have a novel
food." ​
The current legislation means that authorisation is linked to an
individual applicant, which means only the applicant can benefit
for the approval and other firms should put through their own
applications before they can market similar products. Under the
draft proposals, companies will not have their application
protected from others using it unless they apply for
exclusivity.
Lagae believes this wouldn't necessarily hamper innovation, as the
draft currently includes a data-protection clause. "This can be
granted only in special cases for newly developed scientific
evidence and appropriate data with a 5-year exclusivity
period,"​ he said.
There has so far been no indication when the revision may be
finalised.